Senior Director, GMP Quality Assurance, Commercial

Syndax Pharmaceuticals is looking for a Senior Director, GMP Quality Assurance, Commercial

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role: 

Reporting to the Vice President, Head of Quality, The Senior Director Quality Assurance will provide leadership, expertise and guidance on Good Manufacturing Practice for all Syndax commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective actions, risk mitigation.  They will have overall responsibility for the GMP QA Commercial team and daily commercial GMP operations at Syndax CMOs and ensuring internal Quality Operations are in compliance with GMPs and Company policies and procedures. They will collaboratively work with internal functions and external vendors to promote a high level of quality.  They will have overall responsibility for all GMP commercial vendors and will be responsible for assuring product quality including oversight of, but not limited to:  manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for both commercial and clinical distribution. They will support and help to lead a company-wide culture of sustainable GMP and Quality compliance.

Key Responsibilities:

• Serve as a Quality strategic leader on the Quality Leadership Team to represent the oversight and management of the Commercial QA team to support commercial products. 
• Provide oversight to and actively manage the Commercial Quality Operations team.
• Provide expertise in GMP compliance interpretation, consultation, training, and recommendations.
• Collaborates cross-functionally other functions, such as CMC, Regulatory, Development QA, as needed to ensure alignment and best practices.
• Manage the team by planning and developing and attracting talent and ensuring that the team’s capabilities meet Syndax’s future needs.
• May provide support by writing/revising Quality SOP’s, and performing QA review and approval of external and internal generated documents/reports (Master Batch Records, Executed BR’s, specifications, methods, validation docs, and other GXP Documentation).
• Support Annual Product Quality Review efforts. Working cross-functionally, coordinates efforts to gather the necessary information (from CMC, Regulatory) to support APQR.
• Ensure implementation of a robust Vendor Oversight Program for Commercial Vendors.
• Ensure generation and maintenance of Quality Technical Agreements with Contract Service Providers.
• Support development opportunities, and mentor and coach QA team members.
• Support the risk based GMP audit and compliance strategy. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Senior Management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
• Lead investigations into significant quality issues with focus on product impact and patient safety; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
• Support Quality Management Reviews as SME to Commercial Quality Metrics.  Analyze, report, and present metrics to functional teams and Quality management; Identify any risks and recommend any required actions and monitor implementation of mitigation or preventive actions.
• Identify and mitigate GMP activities and process improvement initiatives.
• Work closely with Quality Assurance team to ensure alignment and compliance with Syndax Quality Systems and other GXP functions.
• Work independently and lead a high-performing team, with guidance from manager and senior staff.
• Must be able to articulate complex issues clearly verbally and written.
• Author, review, and/or approval documents including deviations, SOPs, and protocols.
• In collaboration with the Head of QA, lead or provide significant SME support for GMP regulatory inspections; provide GMP compliance technical support during inspections. Facilitate appropriate and timely inspection responses and follow-up actions.
• Experience in implementing GMP inspection readiness program, including mock inspection activities. 
• Demonstrated experience leading and hosting GMP audits, including health authority audits.

Desired Experience/Education and Personal Attributes:

• BS degree in scientific field required, advanced degree preferred.
• Minimum of 12 years of experience in the pharmaceutical industry, within QA/GMP environment.
• Minimum of 5 years managing high-performing teams, including mentoring and staff development
• Experience in data collection and metrics.
• Internal and external auditing experience, including lead auditor role.
• Small molecule experience required (drug substance/API, drug product, packaging and labeling) and QC/analytical. Oncology experience a plus.
• Must have experience working in cross-functional teams including CMC, analytical, supply chain, and regulatory affairs, medical affairs, and commercial.
• Experience working with external vendors and suppliers including drug substance/API, drug product, analytical, and/or secondary packaging and labeling.
• Experience using QMS (including electronic systems), including documents and SOPs, change controls, deviations, product complaints, and annual product reviews. Familiarity with Veeva a strong plus.
• Self-motivated leader with extensive knowledge and application of 21 CFR 210/211 and Part 11, ICH GMP, and applicable global regulations.
• Advanced knowledge in the conduct and reporting of audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to product quality and GMP adherence.
• Experience preparing for and participating in GMP regulatory inspections.
• Strong technical writing skills; ability to write clear quality position statements, risk-based audit reports, and procedures.
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
• Ability to rapidly synthesize complex issues and identify risks in a pragmatic way.
• Excellent communication skills.
• Self-motivating, proactive and independent.
• Consistently demonstrates and models enthusiasm, positive approach and leadership in identifying, embracing, often leading enhancements, improvements and changes with a bias for scalability, efficiency and continuous improvement.

Location: Syndax’s corporate office is in New York, NY.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $250,000 - $285,000.

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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